Safety and Efficacy of Balloon Sinus Dilation in Children

• Published in: Otolaryngology-head and neck surgery 2008-08, Vol.139 (2), p.P68-P68
• Main Authors: Ramadan, Hassan H, McLaughlin, Kevin E, Josephson, Gary D, Rimell, Frank L, Bent, John P
• Format: Article
• Language: English
• ISSN: 0194-5998; 1097-6817
• DOI: 10.1016/j.otohns.2008.05.218

Objective The safety and feasibility of balloon catheters to dilate obstructed sinus ostia was established in adults in the CLEAR study. This minimally invasive approach to endoscopic sinus surgery is potentially advantageous for pediatric patients due to possible decrease in scarring, post-operative pain, and need for operative debridement. This is a preliminary report on the safety and efficacy of using balloon sinuplasty instruments. Methods A prospective, multi-center, non-randomized evaluation is currently underway in pediatric patients diagnosed with chronic rhinosinusitis. To date, 35 patients (58 maxillary, 9 sphenoid, and 3 frontal sinuses) have been enrolled at 5 sites. Safety was assessed by rate of adverse events. Effectiveness was assessed through measurement of patient sinus symptoms. Patients age 12 and older completed the Sino-Nasal Outcome Test (SNOT 20). Parent/guardians completed the SN-5 Questionnaire for patients under age 12. Results No unanticipated adverse effects were noted in any patients. Patient symptoms improved on the SN-5 from average scores of 4.7 at baseline (n=24) to 2.7 at 12 weeks post-surgery (n=11)(p = 0.0001). Patient symptoms improved on the SNOT-20 from 1.7 at baseline (n=10) to 0.9 at 12 weeks post-surgery (n=5)(p = 0.33). Twelve week follow-up data for the entire cohort is anticipated by June 2008 and the abstract will be updated accordingly. Conclusions Preliminary results indicate that when patients are appropriately selected, sinus ostial dilation using balloon catheters in children has an excellent safety profile and may be an effective minimally invasive treatment option to relieve sinus ostial obstruction.